← Product Code [JLW](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JLW) · K922736

# KODAK AMERLITE TSH-30 ULTRASENSITIVE STANDARD SERA (K922736)

_Eastman Kodak Company · JLW · Jul 10, 1992 · Clinical Chemistry · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JLW/K922736

## Device Facts

- **Applicant:** Eastman Kodak Company
- **Product Code:** [JLW](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JLW.md)
- **Decision Date:** Jul 10, 1992
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 862.1690
- **Device Class:** Class 2
- **Review Panel:** Clinical Chemistry

## Regulatory Identification

A thyroid stimulating hormone test system is a device intended to measure thyroid stimulating hormone, also known as thyrotrophin and thyrotrophic hormone, in serum and plasma. Measurements of thyroid stimulating hormone produced by the anterior pituitary are used in the diagnosis of thyroid or pituitary disorders.

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**Source:** [https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JLW/K922736](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JLW/K922736)

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